UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot study to explore additional indication of therapeutic hypothermia for neonates
Title of the study (Brief title)	Additional indication of hypothermia for neonates
Region	Japan

Condition
Condition	Neonatal encephalopathy
Classification by specialty	Neurology Obsterics and gynecology Pediatrics Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety of moderate systemic hypothermia for 72 hours in neonates who are either slightly (i) less matured (33-35 weeks), (ii) less severely asphyxiated, (iii) mildly encephalopathic, or (iv) older (6-12 hours) than those cooled in previous phase-III trials.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Death or severe adverse events until hospital discharge
Key secondary outcomes	Days on mechanical ventilation Age at hospital discharge Requirement for tube-feeding at discharge Death or moderate disability (Time Frame: Birth to 18-22 months corrected age) Brain MRI findings (Time Frame: 5-14 days)

Base
Study type	Interventional

Study design
Basic design	expanded access
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Other
Interventions/Control_1	Induced whole-body cooling with a target core body temoerature of 33.5C for 72 hours
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	1 days-old <=
Age-upper limit	1 days-old >=
Gender	Male and Female
Key inclusion criteria	Neonates are first assessed using the standard criteria for therapeutic hypothermia* (Shankaran et al. NEJM 2005). 1. Neonates born at 36 weeks gestation or greater, and body weight >1799g 2. Postnatal age < 6 hours after birth 3. At least one of the following criteria: - Apgar score 0-5 at 10 minutes - Cord or first postnatal blood pH less than 7.0 - Cord or first postnatal blood Base deficit greater than 16 mEq/L - Need for continued resuscitation at least 10 minutes 4. Abnormal neurological exam suggesting the presence of moderate or severe encephalopathy Neonates who meet 3 of 4 criteria are assessed for eligibility using the following entry criteria. Category 1: Neonates < 36 weeks gestation but > 33 0/7 weeks, and/or body weight between 1500g and 1799g. Category 2: Neonates between 6 and 12 hours of birth when cooling is initiated. Category 3: At least one of the following criteria: - Apgar 0-5 at 5 minutes - pH less than 7.1 - Base deficit greater than 10 mEq/L Category 4: Abnormal neurological exam suggesting the presence of mild encephalopathy
Key exclusion criteria	Gestational age <33 weeks or body weight <1500g. Older than 12 hours of birth. Neonates deemed inappropriate for cooling because of critical clinical conditions, such as severe haemorrhagic diathesis, congenital malformations, infection and cardiopulmonary failure.
Target sample size	30

Research contact person
Name of lead principal investigator	Osuke Iwata
Organization	Kurume University School of Medicine
Division name	Dept of Paediatrics
Address	67 Asahimachi, Kurume, Fukuoka, 830-0011 Japan
TEL	0942-35-3311
Email	oiwata@med.kurume-u.ac.jp

Public contact
Name of contact person	Kennosuke Tsuda
Organization	Yokohama City University Medical Center
Division name	Pediatrics
Address	4-57 Urafune, Minami, Yokohama, Kanagawa, Japan
TEL	045-261-5656
Homepage URL
Email	kentsuda1222@hotmail.co.jp

Sponsor
Institute	Kurume University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Committee on Resuscitation, Japan Society of Perinatal and Neonatal Medicine
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 30 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2018 Year 12 Month 01 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 01 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 01 Month 14 Day
Last modified on	2019 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022621